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The FDA today announced the approval of Cabenuva (Cabotwe and Lipivirin, injection preparations) developed by ViiV Healthcare as a complete solution for treating adults with HIV-1 infection who develop viral inhibitions after receiving antiretroviral therapy.
these patients had no history of failed treatment and no known or suspected drug resistance to cabotway or lipivellin.
this is the first FDA-approved full injection program for adult HIV-infected patients, only once a month.
FDA has also approved the listing of Vocabria (Cabotwe, tablet preparation), which should be used in union with oral lipivirin for 1 month before starting Cabenuva therapy to ensure good drug resistance before conversion to a slow-release injection preparation.
the use of antiviral "cocktail" therapy to treat HIV infection is one of the most important advances in medicine over the past 25 years.
there are already a variety of effective control of HIV-1 virus proliferation of single-piece combination treatment options, as long as patients adhere to daily medication, their life expectancy and healthy people are not significantly different.
, however, if patients are unable to take their medication daily for some reason, the virus may not only make a comeback, but also increase the risk of developing resistance.
before the birth of healing therapy, daily medication was still a burden for many people living with HIV.
Cabenuva is a long-acting antiviral therapy for intramuscular injections.
it consists of two active ingredients, Lipivellin and Cabotwe.
is an oral non-nucleoside retrovirase inhibitor.
is an integrated enzyme inhibitor that inhibits the integration of viral DNA into the genomes of human immune cells.
this integrated step is an indispensable step in the process of HIV replication and an important cause of chronic infection.
Cabenuva and Vocabria have been granted fast-track and priority review qualifications by the FDA.
the safety and effective of Cabenuva were supported by two randomized, open-label, controlled clinical trials.
the results of two clinical trials called ATLAS and FLAR have been published in the New England Journal of Medicine (NEJM).
results showed that a monthly injection of Cabenuva in the hip muscles was equivalent to suppressing HIV-1 viral RNA levels in patients after 48 weeks of treatment compared to daily oral antiviral therapy.
and no clinically relevant changes in CD4-positive cell count compared to baseline were observed.
" currently, standard treatment for HIV patients includes taking pills daily to manage their condition.
," said Dr. John Farley, director of the Infectious Diseases Office at the FDA's Center for Drug Evaluation and Research, "this approval will allow some patients to opt for monthly injections instead of daily oral treatments."
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